FDA has announced an emergency use authorization for Abbott’s BinaxNow COVID-19 Ag Card — a speedy antigen test for the virus that can be directly read off the testing card. The agency in the announcement yesterday evening compared the test’s design to some pregnancy tests. A healthcare provider swabs the patient’s nose and twirls the […]
coronavirus
Here at MassDevice — medtech's online business journal — we're covering news about the coronavirus (COVID-19) pandemic daily. Here is the latest about coronavirus and the medical device industry, regulatory changes related to the pandemic, new tests for the virus, vaccine development, and much more.
HHS to release 1.5M N95 respirators to nursing homes
HHS will release 1.5 million N95 respirators from the Strategic National Stockpile for distribution to approximately 3,336 nursing home facilities across the United States. The respirators, made in the U.S. by the Halyard business of Owens & Minor (NYSE:OMI), will go to select nursing homes that recently reported only enough supplies for only zero to three […]
Hahn apologizes for convalescent plasma claim
Under intense criticism for his statement that convalescent plasma donated by former coronavirus patients could reduce COVID-19 deaths by 35%, FDA commissioner Stephen Hahn apologized on Twitter late Monday. The agency announced on Sunday that it had granted an emergency use authorization (EUA) for plasma donated by coronavirus survivors as a treatment for new patients. President Trump, […]
Report: 20,000 COVID cases traced to Boston medtech company’s conference
The “super-spreading” event held by Biogen (NSDQ:BIIB) in February reportedly led to approximately 20,000 COVID-19 cases across four Massachusetts counties. According to a Boston Globe report, the international company meeting at the Marriott Long Wharf hotel in Boston was said to have resulted in 99 identified cases of the virus, but, according to scientists studying early cases, that […]
Dräger boosts N95 mask production with new U.S. facility opening
Dräger announced today that it is opening a new production facility in Pennsylvania to manufacture N95 respirator masks. Telford, Pa.-based Dräger’s new production facility is located in Montgomeryville, Pa., and is set to begin production in September 2020 with 50 highly skilled jobs slated to be added to the local community. Get the full story […]
Feds’ convalescent plasma claim questioned
Scientists are questioning the Trump administration’s claim for the effectiveness of convalescent plasma in preventing deaths from COVID-19, according to published reports. President Trump and the heads of the FDA and the Department of Health and Human Services all said on Sunday that plasma donated by former coronavirus patients has reduced deaths by 35%. Their […]
Medtronic’s recovery ‘faster than expected’ during its Q1
Medtronic (NYSE:MDT) shares ticked up today on first-quarter results that came in ahead of the consensus forecast. The Fridley, Minn.-based company posted profits of $491 million, or 36¢ per share, on sales of $6.5 billion for the three months ended July 31, 2020, for a -44% bottom-line slide on a sales decline of -13.2%. Adjusted to […]
Report: Top FDA official vows to quit if vaccine approved prematurely
A top FDA official has threatened to resign if the Trump administration moves too quickly to approve a vaccine for COVID-19, according to a published report. Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), made the threat over concerns a vaccine would be approved without being proven safe and effective, […]
FDA grants EUA to convalescent plasma
The FDA yesterday granted emergency use authorization (EUA) for investigational convalescent plasma in treating hospitalized COVID-19 patients. According to the FDA, the product may be effective in treating the virus and its known and potential benefits outweigh the known and potential risks, based on available scientific evidence. The announcement came amid pressure put on the […]
The top 5 medtech CEO quotes about COVID-19
The latest earnings season not only provided insights from top medtech CEOs about how the COVID-19 pandemic is changing the industry, but also lessons learned going forward. Here are five top quotes about lessons learned. Next>> DeviceTalks editorial director Tom Salemi contributed to this report.
HHS pulls FDA back from regulating some COVID-19 tests
FDA will no longer require a premarket review of laboratory-developed tests during the COVID-19 pandemic, according to a decision announced on the U.S. Department of Health and Human Services website. Such a requirement in the future will need notice-and-comment rulemaking versus guidance documents, compliance manuals, website statements or other informal issuances, HHS said in the decision […]